Orthodontic treatment goals are to provide patients with properly aligned teeth, a functional occlusion, and optimal facial and jaw aesthetics and focuses on diagnosis, therapy, and treatment of dentoalveolar and skeletal malocclusions, or generally straightening and positioning teeth for the health, comfort, safety and aesthetics of the patient. Orthodontic treatment frequently relies on the use of removable orthodontic protraction headgear appliances to provide forces to teeth and facial bones in order to correct spatial malrelations between the teeth and/or jawbones. The removable nature of these appliances requires the orthodontic patients, typically growing children and adolescents comply with the orthodontist's treatment to wear the orthodontic protraction appliance. Unfortunately, because of the discomforts associated with orthodontic appliances, poor compliance is the rule rather than the exception with wearing removable orthodontic appliances. Orthodontic protraction headgear appliances have been used since the nineteenth century and discomforts associated with their use have been a faithful cohort. They are a removable type of orthodontic appliance that patients are typically advised to wear 8-12 hours and typically while sleeping.
More particularly, an orthodontic protraction headgear appliance is used in treatment for Class III Malocclusion (underbite) characterized by the lower teeth positioned anterior to or in front of the upper teeth when in centric occlusion. Class III Malocclusion is seen in growing children and adolescents. The etiology involved in Class III Malocclusions can range from a dental condition to a more severe skeletal malrelationship. In Class III Dental Malocclusion, teeth are tipped towards the underbite position with normal maxillary and mandibular relationships. In skeletal malocclusion, the size or relative position of the maxilla and mandible varies. For example, the maxilla can be positioned posterior to an ideally positioned mandible. In another case, the mandible is positioned anterior to an ideally positioned maxilla. Class III Malocclusions may be due to maxillary deficiency and/or normal or slightly prognathic mandible or, at one time, thought of as excessive mandibular growth. Therefore, considerable attention has been given to early treatment using maxillary protraction therapy.
Treatment of Class III Malocclusion, characterized by open bite pattern, is difficult since such malocclusions result from many etiological factors. Skeletal open bite cases are usually associated with an increase in the vertical growth of the maxillary posterior dentoalveolar segments and much of therapy focuses on maxillary protraction with use of reversae pull headgear appliances. The application of conventional reverse headgear, with the associated application of mesially directed force (below the center of resistance of maxillary dentition) tends to increase the anterior open bite. The intrusion of posterior teeth becomes more difficult with age, as mechanical treatment options are limited in adult patients. Orthognathic surgery may be indicated in adult patients with severe open bite and Class III skeletal patterns with retrognathic maxilla. Therefore, compliance to wearing the orthodontic headgear is imperative when the patient is young.
Orthodontic protraction headgear appliances have been used since the 1960's and commercially available reverse pull headgear designs typically have a metal or acrylic intra-oral portion attached to the teeth, and an extra-oral portion or chin cup interface member that presses against the chin of the patient and a forehead pad interface that presses against the forehead of the patient. The protraction headgear appliance also includes a vertical main frame metal bar, metal screws, end caps, and horizontal cross bar which is used with elastic bands. The metal or acrylic intra-oral portion, or horizontal crossbar, is attached to the patient's teeth with elastic bands that exert from 300-800 grams on the right and left sides and also exerts pressure against the patient's chin. The direction of elastic traction is downward and forward at the level of the lips and not parallel to the Frankfurt horizontal plane. This produces a counter clockwise or upward and forward rotation of the maxilla while protracting and backward and downward rotation of the mandible and proclinaction of the maxillary incisors. This method for treating a Class III malocclusion involving a retracted maxilla is to exert a generally mesially directed force on the boney structures of the lower face by engaging the upper arch of the orthodontic patient. These types of force stimulate bone growth to advance the maxilla mesially and/or orthodontically advance the patient's detention. Pressure is also applied to the wearer's facial skin at the chin by the point of force of the headgear chin cup. Pressure is also applied against the wearer's facial skin at forehead by the point of force of the headgear forehead pad. Undesirable side effects are associated with the device that contribute to discomfort to the patient and non-adherence to the treatment. Therefore, a soft absorbent cushiony cover for the orthodontic protraction headgear chin cup interface and the headgear forehead pad interface is needed to assuage the discomforts of the appliance and increase compliance.
The present invention is a protective cover assembly, method for use, and pattern for forming said protective cover assembly, for a chin cup interface and forehead pad interface of an orthodontic protraction headgear appliance to provide an absorbing means, cushioning means, and buffering means, to enable protection against deposits of saliva and perspiration, formation of cracked skin, breakouts, redness, lingering facial indentations, suction marks, irritation, discomfort, pressure sores, decubitus sores, microbial infection, allergic reactions, and other skin disorders, and to consequentially improve comfort while an orthodontic patient is wearing the orthodontic protraction headgear appliance and thereby improve compliance among patients during treatment of Class III Malocclusion disorder. It is an important to note that the protective cover assemblies, according to the preferred embodiment of the present invention do not interfere with the two important issues of orthodontic protraction treatment, i.e., friction and management of forces on the teeth.
This present invention is directed toward assuaging discomforts associated with use of the orthodontic protraction headgear appliance by providing comfort with an absorbing, cushioning, buffering membrane which is positioned between the patient's chin and the hard surface of a chin cup interface; and by providing an absorbing, cushioning, buffering, membrane which is positioned between the patient's forehead and the hard surface of the forehead pad interface to absorb, cushion, and buffer against the impact of the forces of the interfaces. One of the paramount objectives of the protective cover assemblies of the present invention is to increase comfort to the orthodontic patient and thereby decrease nonadherance to the treatment of Class III Malocclusion due to discomforts associated with the use of the orthodontic protraction headgear appliance.
The orthodontic protraction headgear appliance includes a chin cup interface and a forehead cup interface which forces varying pressure against the wearers chin and forehead to assist in the therapy for Class III Malocclusion disorder. The chin cup interface and forehead pad interface includes a hard surface, typically plastic, or other material, which when in use leans closely and tightly against the wearer's chin and forehead and as a result, when using the orthodontic protraction headgear appliance properly, the wearer can incur skin irritation, pressure sores, decubitus sores, redness, irritation, cracked skin, skin allergies, lingering facial indentations, breakouts, or other skin disorders, at the site of the chin and the forehead. More particularly, when the patient is using the orthodontic protraction headgear at night while sleeping, the patient is attached to the appliance at the horizontal cross bar by rubber bands stretching through his/her mouth and hooking to hardware surrounding his/her teeth. This situation fosters drool, saliva, mouth leaks, oral flora, to leak down the wearer's mouth and into the area between the wearer's chin and the orthodontic protraction headgear chin cup interface which consequentially supports an ideal environment for the growth of pathogenic microorganisms or the growth of opportunistic microorganisms. Together with the pressure of the chin cup interface which causes skin irritation, cracked skin, pressure sores, decubitus sores, and the like, an environment is created which provides a medium for cultivation which may support the growth of cultures of known skin pathogens, the likes of Methicillin Resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes (impetigo), Tinea (ring worm), Herpes species virus.
In general, pressure sores, and decubitus sores may form on parts or portions of a patient's skin and body when in contact for a prolonged period of time with an object, such as for example, in this instant case, an orthodontic protraction headgear interface that exerts a pressure against the human facial skin. These sores can be seen in patients who are wearing the orthodontic protraction headgear appliance during treatment of Class III Malocclusion, where the pressure sores develop within soft tissue of the chin and the forehead that is compressed between the hard surface of the orthodontic protraction headgear interfaces a patient's weight-bearing bony prominences. In addition, pressure sores develop depending on the external environmental factors including the firmness and friction of the supporting surface against the patient's skin, the patient/ambient temperature, the amount of moisture in contact with the skin, and the health and susceptibility of the skin due to age or illness or pre-existing skin irritation, and hygiene.
Here, particularly, the pressure exerted on the skin covering or surrounding the chin boney prominences and the forehead boney prominences on the portions of the patient's body that are in contact with the hard surfaces of the orthodontic protraction headgear chin cup interface and the headgear forehead pad interface can result in the patient's facial skin and/or underlying tissue associated with the chin and forehead becoming inflamed, cracked, open, and may obstruct or restrict the blood flow to the skin and/or the underlying tissue, causing the skin and underlying tissue to become ischemic, eventually resulting in the development of pressure sores, or decubitus sores. Decubitus sores can form in any area of tissue covering a bony prominence that is in contact with the hard plastic surface of the orthodontic protraction headgear interfaces upon which the patient's face and skin is congruently pressing therewith.
Moreover the orthodontic protraction headgear chin cup interface and forehead pad interface may apply sufficient pressure to the wearer's chin and forehead resulting in discomfort and skin irritation, red marks, lingering linear indentations on their faces, and suction marks, after only several hours of use of the orthodontic protraction headgear appliance. In addition, the chin area and the forehead portion is distorted beyond its normal range of elasticity to conform to certain facial contours dictated by the headgear interfaces, thus requiring the application of excessive forces to create a seal between the wearer's chin and the chin cup interface and to create a seal between the wearer's forehead and the forehead pad interface. In most cases, these excessive forces may cause the wearer's chin and forehead to distort to conform to the chin cup interface and the forehead interface which increases wearer discomfort, facial soreness, cracked skin, and ulceration.
Initially, pressure on the chin skin and the forehead skin and underlying tissues may lead to pink coloration and/or mild inflammation, which may linger for a few hours of relieving pressure on the chin or the forehead when removing the orthodontic protraction headgear appliance. If pressure is not relieved for a long time, such as when the patient is sleeping while wearing the orthodontic protraction headgear appliance, superficial lesions can form on the chin facial skin, and the forehead facial skin, then developing into sores which continue growing deeper until extending toward the bones and to the blood system and can become infected and manifest as impetigo, MRSA, or hand—to mouth—to eye pink eye infections, to name a few. Commonly known pathogens isolated from pressure sores and decubitus sores are MRSA, Streptococcus pyogenes, Candida albicans. Other skin infections which can arise may be caused by Tinea forming ring worm. Hand—to mouth—to eye infections which may incur can be caused by infectious organisms Streptococcus pneumonia and Haemophilus influenza. 
A conventional means for preventing the development of pressure sores and decubitus sores is to reduce the amount of time a specific body part is subjected to straining pressure; using specialized materials designed to lessen the weight-pressure that is brought to bear on the patient's bony prominences; and medicinal treatments and methods of treating the sore after it occurs. Here, in this case, it is to the detriment and against the teaching of successful treatment of Class III Malocclusion disorder to reduce the amount of time the patient must wear the orthodontic protraction headgear appliance. Reducing time the patient wears the headgear eventually extends the life of the treatment which is disadvantageous because as time progresses the patient grows older and the orthodontic disorder is harder to correct. It is a detriment to wait until the cracked skin and sores appear because orthodontic treatment would also have to be paused and the treatment of antibiotics on pressure sores can induce development of resistant bacteria, for example, MRSA and Vancomycin Resistant Enterococcus (VRE). Therefore, a means for mechanically alleviating the amount of straining pressures imposed on the chin and forehead is critically needed. There is no orthodontic protraction headgear appliance that soothes the amount of pressure imposed by the chin and forehead interfaces against the wearer's chin and forehead, and underlying tissues.
As mentioned, the orthodontic patient who must wear the orthodontic protraction headgear appliance during treatment for Class III Malocclusion disorder is vulnerable to cultivation by pathogenic microorganisms or opportunistic microorganisms at the site of the chin and forehead compressed under contact with the chin cup interface and forehead pad interface. As a result the wearer of the orthodontic headgear appliance is susceptible to eye infections when perspiration and moisture formed between the skin of the wearer's forehead and the headgear's forehead cup becomes infected and contaminated with microorganisms. Even more so, when a patient applies the rubber bands to his mouth and attaches them to the headgear, the patient may contaminate his hands with oral bacterial flora. It is known that some people in the community are carriers of Streptococcus pyogenes along with the normal bacterial flora of their throats. In addition, Haemophilus influenza can be a cause of epiglottis infections. Both S. pyogenes and H. influenza therefore, can be transferred by hand—to mouth—to the patient's eyes causing pink eye, or other eye infections. In addition, S. pyogenes can cause impetigo around the nose and mouth. In addition, the wearer may be touching the headgear forehead chin and chin cup with his hands while adjusting it to relieve discomfort. Contamination to the forehead area and the chin area from unwashed hands is likely to occur.
A patient wearing the orthodontic protraction headgear appliance and subject to at least 12 hours of wear and pressure upon the bony areas of the chin and forehead can promote the infestation and cultivation of fungal infections. Fungi cause a wide variety of diseases in humans. Some fungi cause infections to the outermost layers of the skin (superficial mycoses), other fungi cause cutaneous mycoses by penetrating to the keratinized layers of the skin, triggering pathologic changes in the patient. Derinatophytes, including Trichophyton rubrum and Trichophyton mentagrophytes are fungal infections of the skin or Dermatophytoses. Of particular interest, here, is Tinea barbae or Tinea faciale, which causes erythema, scaling, and pustules in the chin, beard and neck area, or round, bald, scaly patches in the scalp. Secondary bacterial infections may develop from the fungal infection.
For the reason that orthodontic patients are typically growing children or adolescents and who are commonly participants in contact sports, Tinea, or commonly referred to as “ringworm”, is very common concern, especially among children and adolescents, and may be spread by skin-to-skin contact, as well as via contact with contaminated items. Ringworm spreads readily, as those infected are contagious even before they show symptoms of the disease. Participants in contact sports such as wrestling, which is increasingly popular among children and adolescents, have a risk of contracting the fungal infection through skin-to-skin contact. Similarly, MRSA infections have been known reported among participants of wrestling teams. Ringworm is mildly contagious and can be caught from other humans, both by direct contract and by prolonged contact with flakes of shed skin, from sharing clothes, towels, etc. The best known sign of Tinea in people is the appearance of one or more red raised itchy patches with defined annular edges. These patches are often lighter in the center, taking on the appearance of a ring with hyperpigmentation around the circumference caused by an increase in melanin. The affected area may become itchy for periods of time.
Fungal infections have significant effects on a patient's social, occupational, school attendance, and emotional functioning. Feeling of embarrassment may preclude patients from interacting in a social, school, sport, or working environment where they are unwilling to show their face. Moreover, orthodontic patients affected by fungal infections are especially at risk of developing secondary bacterial infections. Medically, fungal infections are very difficult to treat and take a very long time to eradicate symptoms.
Therefore, there is a significant need for the instant invention, as a protective mechanical barrier and membrane for the patient's skin at the site of the chin and forehead against invasive bacteria, fungi, viruses; and to provide protection against the hard surface of the orthodontic protraction headgear interfaces; and prevent the development of pressure sores which may harbor and cultivate microbial contaminants. The present invention satisfies these needs.
When the orthodontic protraction headgear appliance is used by the wearer, holding it in place over the chin or the forehead as the wearer carries on daily routines, or while the wearer is sleeping, can be difficult and uncomfortable due to the pressure applied on the chin and forehead and buildup of perspiration, saliva, and mouth leaks, which causes the orthodontic protraction headgear appliance to slide. In addition, as the wearer naturally moves in his/her sleep the device is likely to shift. More particularly, if the headgear becomes uncomfortable due to irritation of the skin, breakouts, or presence of pressure sores at the site of contact of the chin cup and the forehead cup on the wearer's chin or forehead, the wearer is more than likely to move the headgear by his/her own hand. In addition, the headgear pivotally positioned sufficiently against the wearer's chin and forehead can cause indentations on the wearer's face that can linger for hours after removal of the orthodontic protraction headgear appliance.
The unique advantages of using synthetic fleece material for the construction and manufacture of the present invention's protective chin cup cover assembly and protective forehead pad cover assembly is well apparent as evidenced by its inherent softness, suppleness, lightweight, breathability, cushioning, and quick absorbing and quick drying characteristics that is well suited for imparting comfort and absorbency to the wearer of the orthodontic protraction headgear appliance. Synthetic fleece material is available as polyester fleece and can be readily purchased in neighborhood fabric stores.
Another problem that daunts the orthodontic patient from wearing the orthodontic protraction headgear appliance is the overall unforgiving aesthetic design of the orthodontic headgear appliance. The headgear appliance must be worn and used any time during the day or while the wearer is asleep, including nap time, for the duration of the term of the disorder in order to be effective and successful against the orthodontic challenges presented to a patient with Class III Malocclusion. The headgear appliance is unnatural, cumbersome, medicinal, nuisance, distraction, and unattractive on the face of the wearer.
As a result of the varied discomforts, the wearer is likely to discontinue use of the orthodontic appliance before its effectiveness is apparent. Some orthodontic patients remove their orthodontic headgear at night, at times, not realizing he/she has done so. Some patients choose to discontinue treatment for Class III Malocclusion disorder because of the many difficulties and discomforts associated with adjusting to the orthodontic protraction headgear and nightly treatment. Conventional wisdom among many patients, parents, and orthodontists would agree patient non-adherence is a challenging problem. In addition, to its economic cost, non-adherence can result in protracted treatment and failure to achieve successful orthodontic correction in a timely fashion.
The chin cup interface member and the forehead pad interface membrane of the orthodontic protraction headgear appliance is usually manufactured with hard surfaces, typically plastic, which stains easily from normal use and therefore requires regular cleaning of skin perspiration and skin bacterial flora which intrudes on the surface of the chin cup and the forehead cup. Some orthodontists offer an adhesive synthetic plastic foam pad to peel and stick on to the dorsal side of the headgear interfaces. These adhesive headgear chin cups and forehead cups wear out from repeated daily and nightly use and usually need to be replaced. The orthodontic protraction headgear appliance is costly in itself, therefore incurring additional costs, by repeatedly purchasing disposable accessories, should be prevented.
Orthodontic protraction headgear appliances have similar specifications and use thereof, including a chin cup interface and a forehead pad interface. These structures vary in size of chin cup and forehead cup and dimensions of the appliance varied by the head size of the user. Having little esthetic choices of orthodontic protraction headgear appliance can negatively affect the dedication the patient has toward the therapy and treatment, especially considering the patients' age, the discomfort it presents, and the time needed to successfully correct Class III Malocclusion disorder.
The two aspects of the present invention, a protective chin cup cover assembly and a protective forehead pad cover assembly, which are also of decorative design, provides an improvement to the orthodontic protraction headgear chin pad interface and forehead pad interface, and while enabling the assuagement of the varied problems related with wearing the headgear, and therefore enables patients to remain compliant with treatment of Class III Malocclusion which consequentially promotes successful treatment and correction of the orthodontic disorder. Without treatment compliance, orthodontic disorders are not corrected and may become more pronounced and difficult to correct as the patient ages as their bones grow and teeth change.
A reliable soft, absorbent, cushiony, breathable membranous removable protective cover assembly for an orthodontic protraction headgear chin cup interface and forehead pad interface would be an invaluable improvement to the orthodontic protraction headgear appliance and provide comfort to the patient, and provide for decrease in the occurrence of: cracked skin, redness, breakouts, allergic reactions, pressure sores, decubitus sores, lingering facial indentations, suction marks, and overall discomfort, and provide for increased compliance by orthodontic patients wearing the orthodontic protraction headgear appliance which consequentially would improve the outcome of successful treatment of Class III Malocclusion patients, particularly growing children and adolescents.